TearLab Gets FDA Nod for Wider Use of Eye Test

December 06, 2011

(Reuters) Dec 05 - TearLab Corp said U.S. health regulators granted a waiver that allowed for the wider use of its device to diagnose dry eye.

The U.S. Food and Drug Administration granted the waiver after it reclassified the test as "simple," from "moderately complex" earlier, a company spokesman told Reuters by phone.

"Without a CLIA waiver, an eye practice would need to obtain CLIA certification through paperwork and a 20-hour CME course, as well as maintain this certification through ongoing requirements," Roth Capital analyst Matt Dolan wrote in a note to clients.

"Our feedback from the field indicated that the CLIA certification process has been a significant impediment to adoption of the TearLab Osmolarity System."